510(k) · Cleared
Recalled · 20056060 Multi-Therapy Pump, Model 2M9832; 6060 Epidural Pump, Model 2L9351
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FRN Pump, Infusion
Cleared on Sep 18, 2000 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 11 times.
- Decided
- Sep 18, 2000
- Review
- 21 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 11
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
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- #2 Held for the reportin the report
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What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2005 | Not classified | Z-0412-06 | Other | Failures within the PCA profile as well as incidents resulting in interruptions of therapy in various profiles. |
| Nov 7, 2005 | Not classified | Z-0411-06 | Other | Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test. |
| Aug 17, 2005 | Not classified | Z-1592-05 | Other | Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher |
| Jun 13, 2005 | Not classified | Z-1088-05 | Other | There is an overinfusion condition in the Intermittent mode where the pump may continue to deliver at the higher dose rate instead of switching to the lower keep open rate once the first dose is completed. |
| May 4, 2005 | Not classified | Z-1086-05 | Other | The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow. |
| May 4, 2005 | Not classified | Z-1087-05 | Other | The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow. |
| Nov 19, 2004 | Not classified | Z-0386-05 | Other | A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient. |
| Nov 19, 2004 | Not classified | Z-0385-05 | Other | A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient. |
| Sep 1, 2004 | Not classified | Z-1570-05 | Other | The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid… |
| Sep 1, 2004 | Not classified | Z-1569-05 | Other | The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid… |
| Dec 17, 2003 | Not classified | Z-0376-04 | Other | Premature motor failure. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
https://510kreport.com/device/K002679 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002679: 6060 Multi-Therapy Pump, Model 2M9832; 6060 Epidural Pump, Model 2L9351.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002679
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026